SILICONE RING WITH NEEDLE

Additional Manufacturer Narrative

INVESTIGATION RESULTS: TO DATE THERE IS NO DEVICE AVAILABLE FOR INVESTIGATION. THEREFORE, NO INVESTIGATION POSSIBLE. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED. ON THE BASIS OF THE CURRENT INFORMATION AND WITHOUT THE PRODUCT FOR INVESTIGATION, A CLEAR CONCLUSION CAN NOT BE DRANWN. THERE IS NO INDICATION FOR A MATERIAL DEFECT OR MANUFACTURING FAILURE ON THE BASIS OF THE DEVICE HISTORY RECORDS. BASED ON OUR EXPERIENCE OF PREVIOUS INCIDENTS, IT MIGHT BE POSSIBLE THAT AN IMPROPER HANDLING OR A OVERLOAD SITUATION EXISTED. A CAPA IS NOT NECESSARY.

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SILICONE RING. ACCORDING TO THE CUSTOMER DESCRIPTION, IT WAS REPORTED THAT AFTER A YEAR OF THE SURGERY, THE NEEDLE OF PL595SU WAS FOUND IN THE PATIENT'S BODY, ACCORDING TO THE CT INFORMATION. AS THE MOVIE AT THE SURGERY WAS CHECKED, WHEN REMOVING THE CLIP HOLDING WITH THE APPLIER, AT THE TIME OF TAKING OUT OF THE ORGAN RETRACTOR, IT GOT STUCK WITH THE TROCAR AND THE NEEDLE DROPPED OUT OF THE SILICONE RING. IT HAS BEEN A YEAR AFTER THE SURGERY WITHOUT NOTICE OF REMAINING THE NEEDLE INSIDE OF THE BODY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4).